Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6-8 and 11-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wong et al; Effects of a Novel Beta Lactam Compound, MC-100093, on the Expression of Glutamate Transporters/Receptors and Ethanol Drinking Behavior of Alcohol-Preferring Rats, Pharma Journal, December 2022, Pages 208-216.
Regarding claims 1, 6-8 and 11-22, Wong teaches a method for the treatment or preventing alcohol dependence comprising administration of the novel beta lactam compound MC-100093,
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(3S, 4R)-3-((R)- (1-hydroxy-ethyl)-4-((R)-[1-methyl-2-(4-methyl-piperazin-1-yl)-2-oxo-ethyl]-azetidin-2-one (relevant to claims 1, 6-7, 14, 16, 19 and 21) (abstract). The chronic alcohol/ethanol consumption as taught by Wong is associated with dysregulation of the glutamatergic system in the brain and the liver and more specifically the expression of GLT-1, which is upregulated in the liver of chronic alcohol/ethanol consumption subjects. The treatment taught by Wong is of 50 mg/kg of MC-100093 administered by injection, which reduces the expression of glutamate transporter 1 (GL T-1) (relevant to claims 11-13, 15, 17-18, 22) (abstract, Pg. 212 last para.).
Wang additionally teaches the ethanol drinking was associated with the development of fatty liver disease by the upregulation of GLT-1, in which the treatment prevents the development of fatty liver disease (relevant to claim 20) (Pg. 2015, 1st para.). In terms of claim 8, it is known in the art an excipient is used for oral or injection administration of a compound for therapeutic uses.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-5 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al; Effects of a Novel Beta Lactam Compound, MC-100093, on the Expression of Glutamate Transporters/Receptors and Ethanol Drinking Behavior of Alcohol-Preferring Rats, Pharma Journal, December 2022, Pages 208-216 in view of Childers et al. (US Patent No. 9975879).
The teachings of Wong for the above 102 rejections of claims 1, 6-8 and 11-22 is incorporated herein by reference.
Wong additionally teaches the mentioned method for treatment being administered to rats by a study of analyzing ethanol and control water group rats by their brain and liver tissue dissection.
Wong fails to teach the administration of other beta lactam compounds of claims 2-5 of claimed invention as well as administration to a human mammal.
Childers teaches pharmaceutical compositions for the treatment of drug addition, drug withdrawal and diseases or conditions that involve dysregulation of glutamate homeostasis comprising administration of
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, wherein A and R6 is of the same limitations as claimed invention (relevant to claims 2-5) (Pg. 3-4) and a pharmaceutically acceptable excipient (Pg. 5). Childers additionally teaches in a specific embodiment MC-100093 administered at 50 mg/kg to restore GLT-1 expression levels back to normal that are upregulated (Pg. 6).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have administered the compounds taught by Childers to treat alcohol dependence. One would have been motivated to do so from the teachings of Wong on MC-100093, a beta lactam to treat alcohol dependence in a rat model and the teaching of Childers of the parent compound of
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with its embodiments to treat drug addiction and withdrawal. The teachings of Wong and Childers is of the same GLT-1 expression known to be upregulated in alcohol and drug addiction and withdrawals. There is a reasonable expectation of treating alcohol dependence with the compounds of claimed invention from the teachings of Wong and Childers.
One would additionally administer the compounds to human mammals as it is known in the art the testing of animal models is standard practice and routine experimentation to test the efficacy of a therapeutic to be then used in living humans.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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